Assoc. Scientific Director – Translational Medicine
| Company | Neurocrine Biosciences |
|---|---|
| Location | San Diego, CA, USA |
| Salary | $170100 – $246150 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PharmD, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- BS/BA degree in Biology, Chemistry, or related science field and 8+ years of relevant experience OR
- Master’s in Biology, Chemistry, or related science field and 6+ years of related experience OR
- PharmD or PhD and 5+ years of related experience
- Experience in immunoassay development and GxP-based biomarker platform deployment
- Working knowledge of FDA guidance on bioanalytical method validation and related regulatory aspects
- Understanding of biomarker assay validation and lab certification levels to support the intended purpose of clinical assay
- Strong grasp of FDA’s BEST resource with specific knowledge around surrogate endpoints
- Extensive experience working with CROs to support clinical assay development and sample testing
- Excellent communication and presentation skills
- Experience with regulatory filings and interactions
- Demonstrated expertise in Translational Science
- Passion and tenacity to advance patient-focused research
- Strong knowledge of several areas within experimental medicine and biomarker development with deep expertise in at least one area
- Ability to work effectively in cross-functional teams
- Skill in evaluating data and data quality from multiple sources
- Capable of making data-driven decisions that impact project/program success
- Recognized as an emerging thought leader with technical expertise in the field
Responsibilities
- Establishes translational plans for designated programs and participate with senior management to align biomarker strategies to program goals to enable data-driven decisions
- Provides disease biology expertise to clinical study teams and functional areas such as regulatory, clinical development, and clinical operations
- Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value mechanistic insight for future critical decisions
- Collaborates with external opinion leaders, internal clinicians, research scientists and clinical operations to ensure appropriate biomarkers are incorporated within clinical studies validated appropriately for their intended use
- Support identification and development of novel biomarker platforms
- Engage with CROs to develop and validate clinical biomarker assays in a fit-for-purpose manner
- Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs
- Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)
- Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author biomarker sections of regulatory documents (IB, IND sections)
- Remains up-to-date with current information on biomarker regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
- Other duties as assigned
Preferred Qualifications
-
No preferred qualifications provided.